SERVICES

Our experts offer strategic advice on the optimum route to market by evaluating existing data, focusing on the legal requirements and guiding you through the regulatory procedures. Helping your product reach its commercial potential is at the heart of what we do.

STRATEGIC ADVICE

Product positioning and market entry options

Before even starting the process of registering a new food or animal feed product in the EU, it is important to determine the correct legal category and identify the various possibilities of how the product can be marketed.

Does the product really contain a novel food ingredient that has never been consumed in the EU? Are you using a food enzyme in the manufacturing process that may perhaps have to be approved? Is your feed product really a feed additive or is it a feed material? If it is a feed additive, what category are you going to apply for? Some categories may be quicker or cheaper compared to others.

Pen & Tec can supply you with the pros and cons of each situation, advise on the best strategy and identify the most suitable market entry options.

MARKETING OBJECTIVES VS REGULATORY FEASIBILITY

Aligning objectives

Once it’s clear what the correct legal pathway is to register a product, it is important to keep track of the commercial objectives. There may be a gap between what you can do with a product from a regulatory perspective and what you would like to do from a commercial point of view.

For example, can you use the type of claim you are aiming to obtain or is it perhaps better to organise more clinical studies so that the data support a stronger and more useful claim that is targeted specifically to your consumers? Or is it better to spend more money on studies so that you can apply for the feed additive category your commercial team is interested in?

Pen & Tec can help align and manage the objectives of the various interested parties such as R&D, regulatory and marketing, or explain why a certain strategy is not feasible.

DATA ASSESSMENT AND REGISTRATION OPTIONS

Whether the product of concern is a feed additive, novel food, food enzyme, additive or flavouring, it is very likely your team will need to prepare a scientific application proving the product or ingredient is safe for consumers, animals and the environment. In some cases, it may also be required to prove that the product is effective.

Pen & Tec can assist and this is how we do it:

Product category assessment Based on the product description and the intended use we can identify together with your team what the correct product category is. Feed additive? Food enzyme? Novel food? Something else…?

Identification of legal status Once we know the correct category, we can identify the legal status. Perhaps it has already been approved in the EU? Or perhaps the product only has to be notified to the competent authorities and does not require an approval?

Data audit and GAP analysisIf it turns out the product has to approved by the European Commission before being placed on the EU market, we will evaluate any existing data. Perhaps you already have a lot of data available, or perhaps you can use published data.

Depending on the product category, there may be certain data requirements defined by EC/EFSA which have to be included in a technical dossier in order to prove the product is safe. Our team will provide strategic advice regarding the information required and help provide justifications to omit data, whenever possible. Due to our vast experience with the preparation of EFSA dossiers, we often know which information is crucial and which can be left out.

Financial PlanningWe will be able to indicate how much a certain project will cost at each stage of the registration process. The more information we have about the product, existing and missing data, the more accurate the estimate will be.

Timelines and time to marketHow long will it take us to prepare and submit a scientific application? What will happen afterwards? How long before you can start selling it? We can help answer these questions by providing timelines.

REGULATORY AND PROCEDUAL GUIDANCE

Life cycle management of projects

Pen & Tec ensures life cycle regulatory compliance; from initial stages of product development, identification and evaluation of gaps in the data package, budgeting and generating the data required by the authorities, through to achieving regulatory approval. The time it takes to get a new food or feed product authorised can be significantly reduced if the project is well managed. Pen & Tec can support internal regulatory affairs departments when the in-house resources are limited.

Best practices for conducting studies

Pen & Tec can help support applicants in selecting suitable sites to carry out the required studies. We can also assist with designing studies following current guidelines and legislation, preparing protocols, monitoring trials, analysing raw data and statistical output with the appropriate methods, and preparing EFSA-compliant reports.

If the right procedures are followed and checked, questions from the authorities during evaluation can be avoided and unnecessary delays prevented.

Dossier preparation & post-submission support

Pen & Tec can prepare and submit dossiers with all the required information and also help with any issues that may arise after applications are submitted at national or EU level; from providing regulatory strategies to answering questions from authorities (clock-stops). If your application is in difficulty, please contact us and we will help it get back on track!

Pen & Tec provide options for broadening product portfolios, such as the use of a feed additive in a new target animal species. Pen & Tec can also track & manage renewal applications as existing approvals expire, to ensure there are no market access gaps.

ADDITIONAL REGULATORY SERVICES

Pen & Tec has years of experience and knowledge of current legislation that allows us to advise companies on the regulatory requirements for food and feed products in the European Union, one of the largest global markets today. We also offer additional services, which are developed and tailored to client needs, some of which are listed below:

Monitoring of EU legislation changesRegulation and guidelines change frequently. Pen & Tec monitors and anticipates legislation changes in order to give the most up-to date advice to applicants.

Communication with EU authoritiesPen & Tec can be the contact person for your application and manage the communication with EU authorities. This covers services such as submission of applications and dealing with questions from the European Commission, the EU Reference Laboratory, the European Food Standards Agency, or the National Competent Authorities via e-mail, teleconference or face-to-face meetings.

Literature searchesPen & Tec can conduct literature searches for data on the food or feed products, prepare safety assessments or expert reports to strengthen your application. Literature searches are often a useful tool to justify the omission of certain studies.

Training and in-house workshopsWe deliver in-house training and workshops for regulatory teams. These sessions can be tailored and can cover all areas of our expertise, such as study designs and study monitoring to ensure EFSA-compliance, which will prevent unnecessary investments of time and money.

Conference presentationsConference presentations can be tailor-made to client needs at international conferences. These could cover a wide range of topics, such EU regulations or nutritional support for animal and human health.

Many feed additive companies have welcomed the new EFSA guidance on efficacy, which entered into force on 1st September 2018 because the changes bring promising advantages to those considering to broaden their product portfolios. By offering the opportunity to extrapolate existing data to other target species and by reducing the number of required efficacy studies, the updated guidance allows companies to maximise return on investment by extending to other species while, at the same time, working towards the 3 Rs (reduce, refine and replace animals used in scientific studies). The new guidance on target animal safety, which entered into force on 1st May 2018, also allows extrapolation of safety data between physiologically similar species.

At Pen & Tec, we are offering companies species extension bundles, where we can help you to extend your current feed additive authorisation to other target species. In order to take advantage of the species extension, companies can use their existing data to apply for an update to their existing authorisation.

For example, the extrapolation of recent data compiled for certain animals can now be extended the following species:

With these new updates helping EFSA work towards taking the target “3R’s” approach in the industry, Pen & Tec want to help companies make the most of this positive change and will be happy to assist your company in any way that we can.

BREXIT – REGULATING THROUGH UNCERTAINTY

The UK’s self-imposed deadline to leave the EU is looming. With only a few months left to go, many organisations continue to face high levels of uncertainty and unpredictability around what is to come and what the true impact of BREXIT will mean.

The outcome of BREXIT negotiations will require fundamental changes to the UK’s legal and regulatory landscape in the long term.

By its nature, regulation can be something of a reactive enterprise. It is rightly constrained by government policy and legislation, with the speed of enacting regulatory objectives often hampered by extensive consultation, engagement and parliamentary support.

Companies are finding it difficult to take key decisions today, and to plan for the future. What should you be doing to keep your business on track and to best protect the interests of your company, the industry and your customers?

Don’t panic! – Pen & Tec can help.

We understand the challenges are many and difficult. But we also know that uncertainty can offer new opportunities for those who know how to seek them out.

That’s why we’re proud to be at the forefront of helping organisations find new and innovative ways of working that make sense of today and help get ahead of the competition.

Pen & Tec has a representative office in the EU (near Barcelona, Spain) and we are able to provide support and legal advice as BREXIT unfolds, to our clients in both the EU and UK.

In line with the regulatory services Pen & Tec provides, we are happy to assist with:

Strategic advice

Authorisation holder transfer

EU and UK regulatory support

Track regulatory changes and impact/s on the business/product presence on the market